Program Director/Principal Investigator (Last, First, Middle): Bazzano, Lydia ABSTRACT for transition to R33 Phase This proposal will enhance a unique scientific resource that will facilitate valid life-course approaches to define the ideal path to successful aging, leveraging decades of NIH investment and allowing exploration of new hypotheses. This resource will complement data from longitudinal studies with less coverage of early life, thereby advancing the science of successful aging and providing evidence to enable remote assessment of aging-related outcomes, which can then be applied to other cohorts. Specific aims for the enhanced and expanded activities phase (R33) are to demonstrate feasibility and define the best methods for remotely assessing aging-related factors in dispersed epidemiologic cohorts by: Aim #1: Conducting interviews and administering questionnaires to assess mid-life cognitive function, social isolation, multiple chronic conditions, quality of life, functional independence, and physical performance using validated questionnaires and tools, including NIH Toolbox and PROMIS assessments; and Aim #2: Testing the feasibility and validity of assessing risk factor data using mobile technology in an in-home setting. We will evaluate whether remote sample collection (e.g., saliva, stool), physiologic assessments (e.g., heart rate, blood labs, ECG, pulse-wave velocity), objectively-measured lifestyle factors (e.g., physical activity, sleep) and dietary intake assessed by in-home mobile technology produce high- quality research data, compared with the gold standard of in-person visits. To achieve Aim #1, we will identify a random sample of 150 participants from each cohort already participating in the i3C Outcomes study wi ll be contacted by phone, mail and/or email. The research coordinator will obtain consent and will be trained to administer the assessments. The responses will be entered into a study-specific REDCap database, a HIPAA- compliant web-based database available at both Tulane and CCHMC. We aim to recru it subjects with multiple data points across childhood and adulthood, who will have decades of participation. To achieve Aim #2, each cohort will enroll 50 participants (150 total) at the time of phone interview (R33 Aim 1) to participate in an additional feasibility study of wearable technology, and an in-person validation visit. Subjects will be selected by proximity to the clinic site, access to a smartphone, sex (50% male), and race (based on proportion in each cohort). During this phone call, additional consent procedures will be explained, and the in-person validation study visit will be scheduled for the week following the home data collection. A Virtual Clinic study kit will be mailed, along with a paper consent. All participants receiving the mailed in-home devices wil l be scheduled for an in-person clin ic visit at Tulane or CCHMC during the next 1-2 weeks after the in-home testing. During this visit, participants will undergo the following assessments, which will be used to validate the measurements from the in-home devices or the telephone/questionnaire assessments from Aim 1. Milestones and ti meline for R33 phase are presented in the Table below. Deliverables from the R33 phase include: (1) Recruit 450 subjects (150 per cohort) for telephone interviews; (2) Complete in-home and in-person assessments of mobile technology on 150 subjects (50/cohort); and (3) Evaluation of feasibility, acceptabi lity, validity and data quality. Year3 Year4 Year5 Milestones Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Train team in cognitive function and QOL interview techniques (phone & computer) Recruit and conduct telephone interviews Refine protocols & prepare instructional videos for wearable tech devices and in-home sample kits Collect saliva, stool and wearable tech data via Virtual Clinic studv kits In-person validation studies Perform DNA methylation & stool microbiome studies Validation analvses Manuscript & qrant preparation R33 Expanded Activities Phase Aims 1 2a and 2b 0925-0001 (Rev. 03/16) Page _ Continuation Format Page Program Director/Principal lnvestigator(Last, first, middle}: Bazzano, Lyd ia A GRANT NUMBER 5R2 1AG057983-02 CHECKLIST 1. PROGRAM INCOME (See instructions.) All applications must indicate whether program income is anticipated during the period(s) for which grant support is requested. If program income is anticipated, use the format below to reflect the amount and source(s). Budget Period Anticipated Amount Source(s ) 2. ASSURANCES/CERTIFICATIONS (See instructions.) In signing the application Face Page, the authorized organizational representative agrees to comply with the policies, assurances and/or certifications listed in the application instructions when applicable. Descriptions of individual assurances/certifications are provided in Part Ill of the PHS 398, and listed in Part I, 4.1 under Item 14. If unable to certify compliance, where applicable, provide an explanation and place it after the Progress Report (Form Page 5). 3. FACILITIES AND ADMINSTRATIVE (F&A) COSTS F&A costs will not be paid on construction grants, grants to Federal Indicate the applicant organization's most recent F&A cost rate organizations, grants to individuals, and conference grants. Follow any established with the appropriate DHHS Regional Office, or, in the case of additional instructions provided for Research Career Awards, for-profit organizations, the rate established with the appropriate PHS Institutional National Research Service Awards, Small Business Agency Cost Advisory Office. Innovation Research/Small Business Technology Transfer Grants, foreign grants, and specialized grant applications. [8J DHHS Agreement dated: 11/19/2018 D No Facilities and Administrative Costs Requested. -------------------- ? No DHHS Agreement, but rate established with Date ------------------ CALCULATION* Entire proposed budget period: Amount of base$ 205,108 x Rate applied 52 % = F&A costs $ 106,656 ----- Add to total direct costs from Form Page 2 and enter new total on Face Page, Item 8b. *Check appropriate box(es): D Salary and wages base [8J Modified total direct cost base D Other base (Explain) D Off-site, other special rate, or more than one rate involved (Explain) Explanation (Attach separate sheet, if necessary.): Tulane University HSC ch ecklist for Year 3, first year of R33 Phase. PHS 2590 (Rev. 03/16) Page __ Form Page 6